Associate Principal Scientist/Engineer, Medical Device and Combination Products, Analytical
Merck
Summary
The Center for Packaging & Device Analytics (CPDA), within our Manufacturing Division, has responsibility for applied physical, material & analytical science to support production and commercialization of product packaging and drug-delivery medical device/combination-products (MDCPs), such as auto-injectors and pre-filled syringes. We are an interdisciplinary engineering science Center of Excellence that supports the entire global-human-health portfolio and closely partner with various Packaging or Device Technology engineering groups, packaging sites, and partner analytical groups.
Job description
The CPDA is seeking an Associate Principal Scientist/Engineer who, as an individual contributor, can act as an MDCP analytical lead for one or more exciting projects. A key aspect of the role is leadership, within a cross-functional working group, to develop & own both an analytical strategy (to satisfy Design Controls inputs) as well as the timeline, which includes managing analytical efforts.
The role will naturally include substantial technical creative challenge for Device Characterization and more formal Design Verification, which includes development & validation of mechanical test methods as well as coordination & technical oversight for internal CPDA staff or external lab testing (where required) to meet project timelines and deliverables.
To excel in the role, one must be creative and skillful in problem solving and applied experimental physical science relevant to mechanical devices, as well as be a highly effective communicator (written and verbal), collaborator and technical coach. Ideally, the candidate has prior hands-on analytical experience with MDCP and Design Controls.
Requirements
- Ph.D. in Mechanical, Chemical or Biomedical Engineering (or equivalent field)
- Minimum of 3 years with Ph.D. in a role responsible for medical device or combination product development verification, method development and testing
- Experience with mechanical testing, imaging, and measurement equipment and techniques
- Tensile/compression/torsional testing
- Materials characterization
- X-ray computed tomography
- Rheometry
- Microscopy
- Excellent collaboration and leadership skills
- Experience developing Device Characterization and Design Verification strategies/mechanical tests with validations
- Engineering studies, design verification protocols, stability studies and validation protocols
- Selection of acceptance criteria
- Understanding/familiarity of Design Controls (21 CFR 820.30) and relevant industry standards
Benefits
- Medical, Dental & Vision
- Other Insurance Benefits
- 401(k) Retirement
- Paid Holidays
- Vacation
- Compassionate & Sick Days
- Annual Bonus
- Long-Term Incentive
Company overview
Merck & Co., Inc., known as Merck in the United States and Canada and MSD (Merck Sharp & Dohme) internationally, is a premier American multinational pharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891 as the U.S. subsidiary of the German Merck Group, the company became independent following World War I and has since grown into one of the world's largest biomedical companies, ranking fourth globally by revenue. Merck operates across three core business segments: pharmaceuticals, vaccines, and animal health products. The company is renowned for its groundbreaking research and development, having brought numerous life-saving medicines to market including Keytruda (pembrolizumab), a leading immunotherapy for cancer treatment that generated $29.5 billion in 2024 revenue, and Gardasil, a revolutionary HPV vaccine. With approximately 75,000 employees worldwide, Merck maintains a robust pipeline of innovative therapies focused on oncology, vaccines, hospital acute care, cardiology, neuroscience, virology, immunology, and diabetes. The company invests heavily in R&D, spending $17.9 billion in 2024 alone, demonstrating its commitment to advancing scientific discovery. Merck's legacy spans over 130 years of bringing hope to humanity through important medicines and vaccines, operating with a purpose to use leading-edge science to save and improve lives globally while fostering an inclusive workforce and responsible business practices.